Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Saturday, September 1, 2012 Daily Archives

In order to deliver cell-based therapies on a commercial scale, cell therapy companies and suppliers must form partnerships in order to overcome existing manufacturing, regulatory, and analytical challenges. Four leading cell therapy experts discuss what is and what has to be done in order to accomplish this objective.

Promethera Biosciences presents this case study detailing how HHALPC from normal adult livers can be purified, expanded In vitro and utilized to successfully treat patients with Crigler-Najjar disease.

The technological innovations and improvements to cell purification and other cellular analysis-based processes have dramatically increased sample throughput rates resulting in an improved ability to treat cancer, autoimmune diseases, and a range of applications in regenerative medicine.

While cell-based therapies offer huge potential, significant challenges, including GMP manufacturing, scaling-out, and delivery must be addressed and overcome in order to justify and successfully autologous and allogeneic provides to the market.

Clarifying cell culture broth is the first downstream unit operation in an elaborate sequence of steps required to purify a biological therapeutic. A combination of centrifugation, depth filtration, or tangential-flow filtration (TFF) is used for that operation. The availability of large-scale, single-use, depth filtration technology in the recent years, however, has given process developers the capability to improve and simplify downstream processes.

Two case studies are presented highlighting the impact PLEX-ID System can have to rapidly identify virus contaminants resulting in better control of biologics manufacturing process, with the potential to characterize various sources of excursion through genotyping information.

This case study highlights a seven month project to upgrade a 100L stainless steel facility to a 2000L single-use facility without affecting current clinical manufacturing while adhering to cGMP requirements.